BEUDAMED
    FDA Enforcement Class II Ongoing

    Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777

    Recall: Z-0112-2024 · Reported October 25, 2023

    Enforcement

    Recall Number
    Z-0112-2024
    Event ID
    93019
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cardinal Health 200, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 25, 2023
    Initiation Date
    September 13, 2023
    Classification Date
    October 13, 2023
    Address
    3651 Birchwood Dr, N/A, Waukegan, IL, 60085-8337, United States

    Description

    Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777

    Reason

    Syringe contains conical tip that is not compatible with certain needleless IV connector(s).

    Code Info

    Model Number/Product Code: 1180100777. UDI/DI: 10192253034530 each, 20192253034537 box, 50192253034538 case. Lot Numbers: 221201, 221202, 221203, 230201, 230202, 230203, 230204, 230205, 230601.

    Distribution

    Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY

    Quantity

    3.927,994 units